NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Sep 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
4/8 — Partial
Priority Review
PEDMARK (sodium thiosulfate) by Fennec Pharmaceuticals is cisplatin-induced ototoxicity is caused by irreversible damage to hair cells in the cochlea hypothesized to be due to a combination of reactive oxygen species (ros) production and direct alkylation of dna leading to cell death. First approved in 2022.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PEDMARK is an intravenous sodium thiosulfate solution approved to reduce cisplatin-induced ototoxicity in pediatric patients. It works by directly inactivating cisplatin and increasing intracellular antioxidant glutathione levels to mitigate reactive oxygen species-mediated hair cell damage in the cochlea. This is a niche oncology supportive care product addressing a serious adverse effect of a widely-used chemotherapy agent.
Peak12.8 years to LOE
Product is in peak lifecycle phase with limited public spending data; team likely focuses on adoption in pediatric oncology centers and hospital systems.
Mechanism of Action
Cisplatin-induced ototoxicity is caused by irreversible damage to hair cells in the cochlea hypothesized to be due to a combination of reactive oxygen species (ROS) production and direct alkylation of DNA leading to cell death. Sodium thiosulfate interacts directly with cisplatin to produce an…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
Started May 2026
25 enrolled
Solid Tumor MalignanciesTesticular CancerHead and Neck Cancer+1 more
Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985
Started Jan 2022
48 enrolled
Metastatic Breast Cancer
Observational Follow-up to ST-001 Calciphylaxis Pain Treatment With Intravenous Sodium Thiosulfate
Started Oct 2017
5 enrolled
Calciphylaxis
A Phase 3 Clinical Trial of Intravenous Sodium Thiosulfate in Acute Calciphylaxis Patients
Started May 2017
29 enrolled
Calciphylaxis
Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors
Started Jul 2009
17 enrolled
Central Nervous System Embryonal NeoplasmEmbryonal Tumor With Multilayered Rosettes, C19MC-AlteredGerm Cell Tumor+7 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.